SUPPLY CHAIN ARTICLES
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![iStock-997784670-selection-chain]( "Biomanufacturing Capacity Crunch: It's The Supply Chain's Fault")
Biomanufacturing Capacity Crunch: It's The Supply Chain's FaultWhat's behind the protracted biopharma manufacturing capacity crunch, when will it end, and what are manufacturers doing to keep supply on track? During Biotech Week in Boston ad BioProcess International, CDMOs and sponsors weighed in.
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![Man working in vegetable garden-GettyImages-1327986655]( "Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions")
Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future DirectionsOverall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem.
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![Game Strategy-GettyImages-169983235]( "Inside Alnylam's Playbook For High Volume siRNA Production")
Inside Alnylam's Playbook For High Volume siRNA ProductionAs one of the first companies to establish a chemoenzymatic ligation platform, Alnylam's Maines and Nechev are in the perfect position to espouse wisdom on the practical aspects and remaining challenges of implementing enzymatic ligation at a large scale. Here in this installment, Maines and Nechev outline what they’ve learned thus far about the science of enzymatic ligation, while also paying credence to the unknowns and existing barriers that, as a frontrunner, Alnylam will inevitably (but willingly) be tasked with facing in the future.
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![GettyImages-1459917555-lab-research-development-gene-genetic]( "The mRNA Supply Chain Revolution: Materials, Methods, And Momentum")
The mRNA Supply Chain Revolution: Materials, Methods, And MomentummRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.
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![coronavirus covid-GettyImages-1220020527]( "FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities")
FDA Sets Recommendations For Predicting Dangerous Nitrosamine ImpuritiesThe FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
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![Success Transformation, improvement, leadership-GettyImages-1417761158]( "Beyond The Gold Standard(s): Modernizing Oligonucleotide Synthesis")
Beyond The Gold Standard(s): Modernizing Oligonucleotide SynthesisA few weeks ago, I had the chance to sit down with OPT Congress speaker Phil Baran, Richard Lerner Chair Professor, Department of Chemistry, Scripps Research. Baran was slated to (and did) present a keynote on the innovations shaping the next generation of oligo synthesis. Here, I share the biggest takeaways I had from our conversation, touching on how he sees the science of oligo chemistry and manufacturing advancing in the near and far future.
SUPPLY CHAIN VIDEOS
What challenges do you consider the most formidable in your own mRNA therapeutic development environments?
In this opening Advancing RNA Live clip, NanoVation Therapeutics’ Dominik Witzigmann and Stealth Co’s John Zuris share the scientific advancements they’ve been watching most keenly in the LNP space, as well as some of the evolutions they’re seeing in the overall quality of our RNA-LNP products.
While we can make lots of mRNA at a smaller scale, when it comes to scaling up to kg quantities of mRNA, our current batch processes leave a lot to be desired. Together, Stu Sundseth of Tune Therapeutics and Christian Dohmen of Ethris unpack the biggest barriers to scaling IVT to achieve the desired yield and quality of mRNA, offering their take on how the field is innovating to overcome these issues.
With benefits across applications, nanoplasmids are designed to replace antiquated bacterial backbones, while eliminating antibiotic markers that can cause regulatory concerns.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![DNA molecules 450x300]( "Chromatographic Purification Of Plasmid DNA")
Widespread application of pDNA in gene therapy is driving increased demand and as a response, plasmid manufacturing must become more efficient with improved productivity. Intensification of chromatographic steps can help address this demand and has led to an exploration of the use of convective media (monoliths, membranes, fibre based technologies).
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![Thermo ABM pic]( "Delivering Global Media Manufacturing Consistency Through Site-To-Site Equivalency")
Explore a program focused on achieving process consistency through risk mitigation in four key areas: raw materials sourcing, equipment, manufacturing processes, and finished product testing.
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![Warehouse management innovative software GettyImages-1355815870]( "Reducing Lead Time, Delivering >99.5% OTIF")
Explore the stocking solution offered to a mid-sized CDMO in need of a high volume of safety stock inventory to support their customer portfolio growth.
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![scientist iStock-1166567091]( "mRNA Transfection Reagent Enhances Non-Viral Gene Delivery To Stem Cells")
Researchers demonstrate a delivery mechanism that is a simple and ready-to-use transfection reagent that leads to outstanding transfection efficiencies in known hard-to-transfect stem cells.
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![test tubes, dropper, glass vials, pharmaceutical innovation-GettyImages-2157720330]( "Move Beyond LAL")
Uncover how how switching from LAL to rFC can enhance sustainability, improve testing reliability, and strengthen supply-chain resilience in endotoxin testing.
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![Advancing RNA_Primrose Scientific Poster]( "Advancing mRNA Therapeutics With High Performance RNA Polymerases")
Learn how optimized RNA polymerases enhance mRNA therapeutic quality and transcript integrity by increasing yield and capping efficiency while reducing double-stranded RNA impurities.
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![GettyImages-523692032]( "Moderna's Regulatory Journey: 3 Takeaways To Foster The mRNA Renaissance")
The story of how Moderna brought one of the first mRNA vaccines to the market has all the makings of a legend we will pass down through generations. However, unlike the legends of King Arthur or The Fountain of Youth, we can celebrate that Moderna’s legendary journey was — and still is — real. Not only did the mRNA vaccines help return life to normal, but they also kickstarted the mRNA therapeutic renaissance we’re happily experiencing today.
